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The Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years or More
Sponsor: Seoul National University Hospital
Summary
The goal of this clinical trial is to compare the changes in serum urate levels and symptom recurrence after reducing or suspending urate-lowering agents in well-controlled gout patients (the 'after dishes are clean' state in the Dirty Dish hypothesis) Researchers will compare three randomized groups: the reducing group takes febuxostat 20 mg once daily for 12 months, the discontinuing group takes a placebo once daily for 6 months, followed by febuxostat 20 mg once daily for the next 6 months, and the maintaining group continues their pre-study urate-lowering agents for 12 months, serving as an observational reference group. During the 12-month study period, participants will visit every 3 months for laboratory evaluations including serum urate levels, and for checking symptomatic status using questionnaires and diaries. Additionally, musculoskeletal ultrasonography and serum sample collection will be performed at baseline to study predictors for maintaining serum urate levels \<7.0 mg/dL after reducing or suspending urate-lowering therapy.
Official title: A Prospective, Multicenter, Randomized Investigator Initiative Clinical Trial Study on the Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years or More
Key Details
Gender
All
Age Range
19 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
59
Start Date
2024-10-15
Completion Date
2026-10-14
Last Updated
2024-10-02
Healthy Volunteers
No
Interventions
Febuxostat
The minimal approved dose of febuxostat is 40 mg/day. We will use 0.5 tablet of febuxostat 40 mg or its placebo.
Locations (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea